>Assuming that Kamada’s inhaled AAT is approved by the FDA at some point, there are two ways that I can see whereby GTC might break Kamada’s orphan exclusivity...<
I can see a third way: Kamada has a small plant limiting their AAT production capability. They will be able to treat between 1000 to 3000 patients (dose for inhaled use is not known yet). More patients are being diagnosed every year due to better doc's awareness and rapid tests. GTCB will be able to break Kamada’s orphan exclusivity because Kamada will not manufacture enough AAT to meet the market demand.